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临床试验/NCT03417258
NCT03417258已完成不适用

Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon

University of Bari1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Phytoestrogen absorption

研究概览

简要总结

INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have produced conflicting results. The literature suggests that some subclasses of phytoestrogens may have protective effects against CRC and colon adenomas, but most of these results come from population studies based on the dietary intake of phytoestrogens. On these premises, it is possible to hypothesize that the variability of the data reported in the literature may be due to the fact that the real absorption of phytoestrogens (by assessing their concentration in the serum or urine) and/or the ability of the single individual of producing equol was not evaluated.

PURPOSE: In the present study, the association between the phytoestrogens intake and the prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake but also on the measurement their intestinal absorption. Moreover, a specific evaluation of equol production by the intestinal flora was performed. Finally, intestinal bacteria involved in equol production were evaluated.

详细描述

MATERIALS AND METHODS

Patients with sporadic colon adenomas were enrolled in group I (case) and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled in group II (control). All participants underwent the following evaluations: BMI, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens [by high pressure liquid chromatography (HPLC)] and intestinal flora [by mass spectrometry with Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology]. At the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects of both sexes aged between 50 and 75 years
  • colonoscopy within 3 months from the study evaluation

排除标准

  • age < 50 and > 75 years
  • previous diagnosis of colon cancer or inflammatory bowel diseases (IBD)
  • Hereditary intestinal tumors (FAP, HNPCC, ...)
  • ongoing infections
  • intake, in the last 4 weeks, of drugs that alter the intestinal bacterial flora
  • creatinine clearance below 60 ml/min
  • liver failure

结局指标

主要结局

Phytoestrogen absorption

时间窗: one day

It will be evaluated on the basis of their 24h urine excretion

次要结局

  • Intestinal microbiota(one day)

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Barone

Researcher

University of Bari

研究点 (1)

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